About the Role
As a Computer System Validation (CSV) Lead, you will make an impact by leading validation and testing activities for regulated systems while ensuring compliance with industry standards, quality requirements, and customer-approved processes. You will be a valued member of the project delivery team and will collaborate closely with business stakeholders, quality teams, project managers, and technical teams to deliver compliant and high-quality validation outcomes.
In This Role, You Will
• Lead validation testing activities, including test strategy development, test design, execution, and reporting.
• Apply GAMP categorization, CSV/CSA methodologies, 21 CFR Part 11 requirements, and risk-based validation approaches to validation programs.
• Analyze functional requirements, estimate testing efforts, and contribute to project planning and validation strategies.
• Support the preparation, review, and maintenance of testing and Software Lifecycle (SLC) documentation.
• Execute validation activities in accordance with approved processes, procedures, compliance requirements, and training standards.
• Coordinate defect triage activities, analyze test results, and collaborate with cross-functional teams to resolve issues.
• Monitor testing progress and provide accurate daily, weekly, and monthly status updates to stakeholders.
• Ensure timely delivery of quality validation outcomes while maintaining compliance with regulatory and organizational standards.
Work Model
We strive to provide flexibility wherever possible. Based on this role's business requirements, this is a remote position open to qualified applicants within the United States. Candidates located in or near Waukegan, IL, or those willing to work periodically from the client office in Waukegan, are strongly preferred. Regardless of your working arrangement, we are here to support a healthy work-life balance through our various wellbeing programs.
What You Need to Have to Be Considered
• Strong understanding of GAMP categorization, Computer System Validation (CSV), Computer Software Assurance (CSA), and 21 CFR Part 11 requirements.
• Experience applying risk-based validation approaches and developing validation strategies for regulated environments.
• Hands-on experience with validation test planning, test design, execution, defect management, and reporting.
• Ability to analyze business and functional requirements and translate them into validation deliverables.
• Experience creating and maintaining testing and Software Lifecycle (SLC) documentation.
• Strong stakeholder management and collaboration skills with the ability to work across cross-functional teams.
• Excellent communication skills with experience providing project and testing status updates to leadership and stakeholders.
• Proven ability to deliver high-quality validation outcomes within established timelines.
These Will Help You Stand Out
• Experience supporting Life Sciences, Pharmaceutical, Biotechnology, or other regulated industry programs.
• Knowledge of GxP compliance requirements and regulatory expectations.
• Experience leading validation activities across multiple projects or workstreams.
• Familiarity with validation automation, test management, and defect tracking tools.
• Strong analytical, problem-solving, and risk-assessment capabilities.
We're excited to meet people who share our mission and can make an impact in a variety of ways. Don't hesitate to apply, even if you only meet the minimum requirements listed. Think about your transferable experiences and unique skills that make you stand out as someone who can bring new and exciting things to this role.
Salary and Other Compensation:
Applications will be accepted until July 10, 2026.
The annual salary for this position is between $83,250– $131,500 depending on experience and other qualifications of the successful candidate.
This position is also eligible for Cognizant’s discretionary annual incentive program, based on performance and subject to the terms of Cognizant’s applicable plans.
Benefits:
Cognizant offers the following benefits for this position, subject to applicable eligibility requirements:
Medical/Dental/Vision/Life Insurance
Paid holidays plus Paid Time Off
401(k) plan and contributions
Long-term/Short-term Disability
Paid Parental Leave
Employee Stock Purchase Plan
Cognizant will only consider applicants for this position who are legally authorized to work in the United States without company sponsorship.
*Please note, this role is not able to offer visa transfer or sponsorship now or in the future*
À propos de Cognizant
Cognizant (NASDAQ : CTSH) est un AI Builder et une entreprise de services numériques (ESN) élaborant des solutions complètes d’IA maximisant les investissements pour des résultats concrets. Sa profonde expertise des métiers, des processus et des technologies lui permet d’intégrer dans les systèmes technologiques le contexte unique de chaque organisation de l’ingénierie à la production à l’échelle. Son objectif : améliorer l’efficacité des équipes, créer de la valeur et permettre aux grandes entreprises de rester performantes dans un monde qui évolue rapidement. Pour en savoir plus : cognizant.ai ou @cognizant.
Renseignments suppplémentaires sur l'emploi
Les informations relatives à la rémunération du poste à pourvoir dépendent de la date de publication de l’offre de poste. Cognizant se réserve le droit de modifier ces informations à tout moment, sous réserve des lois applicables.
Cognizant est un employeur soucieux de l'égalité des chances entre candidats. Votre candidature sera étudiée indépendamment de votre race, couleur, sexe, religion, croyances, orientation sexuelle, identité de genre, origine, handicap, informations génétiques, grossesse, statut d'ancien militaire ou de toute autre critère jugé discriminant par les lois européennes ou françaises.
Vous êtes porteur d'un handicap, vous pouvez-nous contacter par courriel [email protected] si vous souhaitez préciser les aménagements nécessaires pour le poste ou les entretiens à venir.
Les candidats peuvent être invités à participer à des entretiens en face à face ou par vidéoconférence. En outre, les candidats peuvent être amenés à présenter une carte d'identité valide lors de chaque entretien.
